Accelerated Stability Assessment Program (ASAP) - American ...

More documents

Recommendations

Info

Humidity Corrected Arrhenius Equationcollision frequencyhumidity sensitivity factor1.986 cal/degln k = ln A - E a/(RT) + B(ERH)1/(isoconversion time)equilibrium relative humidityactivation energy10
Aspirin Tablet Degradation70C50C 40C 30C20C75% RH10%RHParallel Arrhenius curves seen at each RH11
Page 1 and 2: Accelerated Stability AssessmentPro
Page 3 and 4: Accelerated Stability AssessmentPro
Page 5 and 6: log kExcipient/API Interactions-0.6
Page 7 and 8: Stability at Different Temperatures
Page 9: 80CArrhenius Plot:Two Approaches70C
Page 13 and 14: Effect of B Values on Shelf Life (C
Page 15 and 16: ASAP Screening-Protocol: Set to Gen
Page 17 and 18: Error Bars for Predicted Shelf-Life
Page 19 and 20: Error Bars for Predicted Shelf-Life
Page 21 and 22: Protocol ExampleFinal protocol may
Page 23 and 24: Protocol ExampleFinal protocol may
Page 25 and 26: Packaged-Product StabilityH 2 OH 2
Page 27 and 28: %H 2 OMoisture Sorption Isotherm—
Page 29 and 30: Moisture Vapor Transmission Rateper
Page 31 and 32: %RHEmpty Bottle/Blister Equilibrati
Page 33 and 34: %RHPredicted (Lines) vs. Measured R
Page 35 and 36: Example 2: More Stable Drug Product
Page 37 and 38: Bridging Science and Regulations•
Page 39 and 40: Acknowledgments• Pfizer scientist

Accelerated Stability Assessment Program (ASAP) - American ...

Create successful ePaper yourself

Delete template?

Save as template?